Ozempic Falsification also in the US

Recommendation

23/24 October 2024

Serialization/Aggregation - Live Online Training
Requirements, Challenges & Solutions

Following the previously confirmed falsifications of Ozempic® batches in the EU drug supply chain, the FDA now warns consumers not to use counterfeit Ozempic® found in the US drug supply chain. The FDA continues to investigate counterfeit Ozempic® (semaglutide) injection 1 milligram (mg) and has seized thousands of units of the product. In addition, the agency advises wholesalers, pharmacies, health care practitioners and patients to check the product they have received and not distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057. Some counterfeit products may still be available for purchase.

The FDA is aware of five adverse events from this lot, none of which are serious and are consistent with known common adverse reactions to authentic Ozempic®, which are nausea, vomiting, diarrhea, abdominal pain and constipation. The agency and the manufacturer of Ozempic® (Novo Nordisk) are testing the seized products and do not yet have information about the drugs’ identity, quality, or safety.

Additionally, analysis found the needles from the samples are falsified. Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products. Based on the analyses completed so far, other confirmed counterfeit components within the seized products are the pen label, accompanying health care professional and patient information, and carton.

Therefore, the FDA recommends pharmacies only purchase authentic Ozempic® through authorized distributors of Novo Nordisk and review the photographs and information provided to confirm the legitimacy of their shipments. Patients should only obtain Ozempic® with a valid prescription through state-licensed pharmacies and check the product before using for any signs of counterfeiting.

For more information together with pictures of authentic and counterfeit needles please see the article FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain.